COMPLETE MoisturePLUS Multi-Purpose Solution (US and Asia Pacific markets, excluding Japan) & COMPLETE Amino Moist Multi

FDA device recall Z-0344-2007 · posted 2007-03-01 · Terminated

Recall details

Recalling firm

Advanced Medical Optics, Inc.

Reason for recall

Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm's plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

Action taken

Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006.

Root cause

Other

Status

Terminated

Product code

LPN

Quantity affected

182,678 units for all US products, 2,943,207 units worldwide

Distribution

Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

Date initiated

2006-09-15

Date posted

2007-03-01

Date terminated

2010-02-17

Location

Santa Ana, CA